Boston Scientific Corporation: EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.

Hazard

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

Details from the source

Reason for recall: Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. Distribution: Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong. Quantity: 16 consoles Lot/code info: Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02146, and CU4.0-02026, UPN 600-40500, GTIN 00858593006462.

UPC codes

00858593006462

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.